biolink Regulatory Column - August 2014

Don't Fear the Audit

As a play on the 70’s song from Blue Oyster Cult, it is good to remember that audits, be they First-Party (internal), Second-Party (customer), or Third-Party (ISO or FDA), are not entirely bad things for a company in the Med-Tech industry. In fact, they can be one of the best ways for a growing company to realize short-comings in, and make improvements to, their Quality System.

Audits, obviously, take time away from the normal workload, so one doesn’t typically solicit audits, but if you go into an audit with the perspective that you can learn more about your systems through audits than most any other mechanism, it changes your apprehension into curiosity, and reduces the stress level of everyone in the room.

It isn’t often that an auditor would come in, perform an audit, and shut down a company. Yes, it happens, but it typically takes a series of egregious events or system failures to get to this dire outcome. More often than not, the auditor is there to make sure, in general terms, that the company’s Quality System is properly defined, and that it is being followed. Most auditors are genuinely interested in helping their clients, and not so much trying to demonstrate that they can rack up the most non-conformities.

The ability to look at an audit as an opportunity for improvement gives the event a more cooperative atmosphere, rather than auditee feeling animosity toward the auditor and being reticent in their answering of questions. Even so, it is still a good idea to answer only the question that was asked, and not offer anything additional. Many ‘findings’ have occurred when people get nervous, keep talking well after the question was answered, and eventually give details on a systemic problem.

Once an audit is concluded, and the observations or findings are identified, it is standard for the management team to review the list, and determine if there are any disagreements. It is fairly common for an auditor to point out something that might be a personal preference, but does not expressly violate a regulation, and it is acceptable to challenge those items. Wherever the finding is accurate, and the team sees that there is room for improvement, it is recommended that the Quality Manager open up a corrective action for each item. The fact that it was an audit finding, especially from a second- or third-party auditor, gives some credibility or urgency to the issue, and it sometimes allows changes to be made where they otherwise might have lost momentum or not gotten approval. This is especially true when the corrective action requires some money to be spent.

In summary, audits are a vehicle for improvement, and if embraced in that manner by the company (and particularly the Quality Manager), they become less of a ‘scary’ thing and more an opportunity to demonstrate to customers that your systems are solid, and that ‘continuous improvement’ is an important part of your company’s culture.